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NCT00765674 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension

A Phase 3 study, sponsored by Novartis.

Completed
Registry status
Phase 3
Development phase
1,191
Enrollment target

NCT00765674: Completed Phase 3 study, sponsored by Novartis.

NCT00765674 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 1,191 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00765674, a Phase 3 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 3
Development phase
1,191 participants
Enrollment target

Study Summary

This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.

Primary Outcome

Blood pressure (BP) was measured at trough (24±3 hours post-dose). The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. If there was \< 0.5 mmHg difference in BP between the 2 arms, the non-dominant arm was used. At each visit, after the patient was in a sitting position with the back supported and both feet placed on the floor for 5 minutes, systolic and diastolic BP were measured 3 times with an automated BP monitor and appropriate si

Interventions

  • DRUG Placebo
  • DRUG Amlodipine
  • DRUG Aliskiren
  • DRUG Hydrochlorothiazide (HCTZ)

Trial Details

FieldValue
Enrollment Target 1,191 participants
Start Date 2008-09
Est. Completion 2009-08
Phase Phase 3
Novartis

265 total trials

What the finished NCT00765674 record still lists

NCT00765674 is an interventional study that assigns participants to a tested intervention. Its 1,191 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00765674 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00765674 about?

NCT00765674 is a clinical study titled "Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension". This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.

What is the current status of trial NCT00765674?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,191 participants. The study started on 2008-09. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00765674?

The interventions under investigation include: Placebo (DRUG), Amlodipine (DRUG), Aliskiren (DRUG), Hydrochlorothiazide (HCTZ) (DRUG).

Who is sponsoring clinical trial NCT00765674?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00765674's enrollment target sits among peer trials

1,191 229th of 2000 higher than 1,772 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00765674, the US trial registry maintained by the National Library of Medicine. NCT00765674 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.